Figure 1.

Study design.

^aWeek‐12 Hidradenitis Suppurativa (HS) Clinical Response (HiSCR) responders through Period B to week 36 or until loss of response [loss of 50% of the abscess and inflammatory nodule (AN) count improvement gained between baseline and week 12], and week‐12 HiSCR nonresponders continued Period B to at least week 26 (and up to week 36). ^bPatients could enter the multicentre 60‐week phase III OLE trial (which evaluated long‐term safety, tolerability and efficacy of adalimumab for patients with moderate‐to‐severe HS), if (i) they completed Period B of their respective PIONEER trial; (ii) achieved HiSCR at entry to Period B of their respective PIONEER trial and then experienced a loss of response (LOR); or (iii) did not achieve HiSCR at the entry of Period B and then experienced worsening or absence of improvement (WOAI) (greater or equal to the baseline AN count on two consecutive visits after week 12, occurring at least 14 days apart). ^cStarting at week 4 after 160 mg (week 0), 80 mg (week 2). ^dStratified by baseline Hurley stage II vs. Hurley stage III (PIONEER I and II) and baseline concomitant antibiotic use (PIONEER II). ^eRerandomization for patients treated with adalimumab in Period A was stratified by week‐12 HiSCR status at entry into Period B and by baseline Hurley stage II vs. Hurley stage III. ^fAdalimumab 40 mg starting at week 16 after 160 mg (week 12), 80 mg (week 14).